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Effect of Gentamicin Lavage of the Axillary Surgical Bed After Lymph Node Dissection on Drainage Discharge Volume

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01700504
Enrollment
40
Registered
2012-10-04
Start date
2011-05-31
Completion date
2012-09-30
Last updated
2012-10-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Axillary Drainage Volume After Lymph Node Dissection.

Keywords

Axillary drainage volume, Lavage with gentamicin solution

Brief summary

The effect of axillary lavage with a gentamicin solution before wound closure will reduce the drainage volume and subsequently day of drainage removal.

Detailed description

Inclusion criteria will be a diagnosis of mammary neoplasms and plans to undergo an elective ALND of Berg´s levels I and II due to axillary metastasis determined preoperatively by core biopsy or evidence of metastasis in the SLNB in the intraoperative or in the differed analysis. Exclusion criteria will be chronic renal failure due to possible toxicity of gentamicin and patients undergoing a modified radical mastectomy. The patients will be randomized by means of an Internet randomization module into 2 groups: those patients undergoing 2 lavages of the axillary surgical bed with normal saline (Group 1) and those ones first undergoing lavage with normal saline followed by a second lavage with a gentamicin solution (Group 2). Surgical dissection will be performed using harmonic scalpel (Ultracision, Ethicon Endosurgery, Johnson and Johnson, Cincinnati, OH, USA). Once finished the ALND, a Jackson-Pratt drain will be left in place and connected to a low pressure vacuum device. Methodology: Irrigation technique and extraction of microbiological samples: The lavage will be performed immediately prior to closure of the wound, once placed the drainage into the cavity. In both groups, prior to the lavage, a microbiological sample from the surgical bed will be obtained with a swab (sample 1), followed by a lavage with 500 ml normal saline. After aspiration of the saline, a new microbiological sample will be obtained (sample 2). In Group 1 a second lavage with 500 ml normal saline will be performed, while in Group 2 the second lavage will be performed with an antibiotic solution, including gentamicin (240 mg) dissolved in 500 ml normal saline. After aspirating this second lavage, a third microbiological sample will be obtained in the same way as the two previous ones, in both groups (sample 3). Indication of drain removal and obtention of sample 4: After discharge, the patient will be asked to quantify the drainage volume daily. Drain will be removed when drainage volume was \<30 ml/day. The drainage volume of the last day was collected in a syringe for microbiological study (sample 4).

Interventions

DRUGAxillary lavage with gentamicin solution

Patients undergoing an axillary lavage with 500ml of normal saline followed by 500ml gentamicin solution

Sponsors

Hospital General Universitario Elche
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
20 Years to 90 Years
Healthy volunteers
No

Inclusion criteria

* diagnosis of mammary neoplasms and plans to undergo an elective ALND of Berg´s levels I and II due to axillary metastasis determined preoperatively by core biopsy or evidence of metastasis in the SLNB in the intraoperative or in the differed analysis.

Exclusion criteria

* chronic renal failure due to possible toxicity of gentamicin * patients undergoing a modified radical mastectomy.

Design outcomes

Primary

MeasureTime frameDescription
Drainage volume7 daysThe drainage volumen between groups (interventional and control)will be analyzed.

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 23, 2026